Status:
UNKNOWN
ACCEL Absorbable Hemostat
Lead Sponsor:
Hemostasis, LLC
Conditions:
Hemostasis
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy ...
Eligibility Criteria
Inclusion
- Pre-Surgery:
- Subject is greater than or equal to 22 years old
- Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
- Subject is willing and able to provide appropriate (Institutional Review Board (IRB) approved) informed consent.
- The subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule.
- The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
- The subject is willing to be treated with a commercially available absorbable gelatin sponge
- During Surgery:
- Subject has not received blood transfusions between screening and application of investigational product or commercially available absorbable gelatin sponge
- There is an estimated TBS surface area of ≤ 60 cm2
- Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow ˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and when control by conventional surgical techniques, including but not limited to suture, ligature and cautery, is ineffective and/or impractical
- There is an absence of intra-operative complications other than bleeding, which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety
- There has been no intra-operative use of adjunct hemostat(s) on the target bleeding site identified for application of the study treatment
Exclusion
- Pre-Surgery:
- The subject is pregnant (verified in a manner consistent with institution's standard of care)
- Subject is lactating
- Subject is currently participating in another investigational device or drug trial or has participated in one in the past 4 weeks (prior to surgery) or is planning to participate in another research study involving any investigational product within 4 weeks after surgery
- Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
- Subject has medical, social, or psychosocial issues that the Investigator believes could impact the subject's safety or compliance with study procedures
- Subject has a known allergy to potatoes
- Subject has a known allergy to porcine collagen/gelatin
- Subject has a religious or other objection to porcine products
- Subject is unwilling to receive blood products
- Subject has history of heparin-induced thrombocytopenia (only for cardiovascular subjects where heparin use is required)
- Subject with a baseline abnormality of INR \> 2.5 or an aPTT\> 100 seconds during screening that is not explained by current drug treatment (e.g. heparin, warfarin, etc.).
- Subjects with platelets \< 100 X 109 PLT/L during screening
- Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) \> 3 X upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit normal for these analytes due to the nature of their disease
- Subject is unwilling or unable to return for the required follow-up after surgery
- During Surgery:
- Subject has an operative bleeding site which the surgeon is unable or unwilling to control with a hemostatic agent
- Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be used during or after identification of the TBS.
- There has been intra-operative use of thrombin on the patient.
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04728087
Start Date
October 26 2021
End Date
January 30 2025
Last Update
July 17 2024
Active Locations (7)
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1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
2
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
3
Washington University in St. Louis
St Louis, Missouri, United States, 63110
4
Washington University in St. Louis
St Louis, Missouri, United States, 63110